Emflon PFR Sterilizing-grade Filter Cartridges

High-flow Hydrophobic Filters for Sterile Gas and Vent Applications

Pall Emflon PFR sterilizing-grade filter Quality and Bio-Safety

cartridges feature Pall’s advanced 0.2 µm
polytetrafluoroethylene (PTFE) double-layer
membranes. They are designed to
completely remove bacteria, viruses and
particles from air and gas streams, even in
the presence of humidity and moisture.
Pleated with very high area into sanitary
single open-ended (SOE) AB style
cartridges, Emflon PFR filters are built to
withstand adverse in situ steaming
conditions in either the forward or reverse
direction. Suitable applications are
fermenter inlet air and exhaust venting,
sterile process air, and sterile venting of
tanks, lyophilizers, and autoclaves.
Features and Benefits
• Pall PTFE membranes
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Oxidizables and pH per USP
Sterile Purified Water
Steam Resistance
• Lot samples multi-cycle autoclave
challenged
* Per lot sample soak or rinse-up flush aliquots.

• Inherently hydrophobic
• Oxidation resistant hardware
• High-flow and low pressure drop
• 100% bacteria retentive in liquids
• 100% virus retentive in gases
• Melt-sealed construction
• Enhanced steaming resistance
• 100% Forward Flow tested
• Water intrusion testable
• Individually serialized
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Validation Guide available

123
 Emflon PFR Sterilizing-grade Filter Cartridges
Technical Specifications

Materials Typical Air Flow Rates(5)

Flow Rate (scfm)
Membranes Double-layer PTFE
0 50 100 150
Support and Drainage Polypropylene, oxidation resistant 250

Core, Cage, End Caps and Polypropylene, oxidation resistant

Adapters 3.0
200
O-rings(1) Silicone

Differential Pressure (mbar)

Differential Pressure (psi)

(1)
Other polymers available 2.5

150
2.0
Removal Ratings
Air and Gases < 0.003 µm, particulate (2)
100 1.5
Liquids 0.2 µm, sterilizing(3)
1.0
(2)
By NaCl CNC particle analysis. Also retains 100% of Brevundimonas diminuta bacteria,
bacteriophage and virus aerosols. 50
(3)
Lot samples of assemblies retain > 107 cfu/cm2 of Brevundimonas diminuta in liquid per 0.5
mod. ASTM F838-83 and FDA guidelines.

0 0
0 80 160 240 320
Nominal Dimensions
Flow Rate (Nm3/h)
Lengths 127 mm (5 in.), 10 in. (254 mm),
= Vent = 2.1 barg = 4.1 barg
20 in. (508 mm), 30 in. (762 mm),
(30 psig) inlet (60 psig) inlet
40 in. (1016 mm)
(5)
Typical initial clean medium ∆P per 254 mm (10 in.) element, air at 20 °C
Diameter 2.75 in. (70 mm) (68 °F). For multi-element cartridges, divide pressure drop by number of
254 mm (10 in.) elements. Non-linear cartridge turbulence factors are
incorporated into housing pressure drop values. For complete assembly
Nominal Filter Area pressure drop, add filter cartridge medium value to housing value at
specified flow rate. For gases other than air or nitrogen, contact your local
0.8 m2 (8.6 ft2) per 10 in. (254 mm) element Pall representative.
0.4 m2 (4.1 ft2) per 5 in. (127 mm) element

Autoclave and Steaming

Operating Conditions(4)
Cumulative Steaming Time
Maximum Differential Pressure and Temperature
165 hours (1-hour cycles) to 140 °C (287 °F)
5.3 bard (77 psid) at 20 °C (68 °F)
Maximum Forward Steaming Conditions
4.1 bard (60 psid) to 80 °C (176 °F)
1.0 bard (15 psid) at 125 °C (257 °F)

Typical Continuous Air Service Life(4) 0.3 bard (4.3 psid) at 142 °C (287 °F)

12 months to 60 °C (166 °F) Maximum Reverse Steaming Conditions

Typical Vent Service Life 0.5 bard (7.3 psid) at 125 °C (257 °F)

6 months to 80 °C (176 °F) 0.2 bard (3.0 psid) at 142 °C (287 °F)
(4)
In air/N2 service or other compatible gases.
For continuous air flow above 60 °C (140 °F), Emflon CPFR filters are recommended. Integrity Test Values for one 10 in. (254 mm) Cartridge(6)
Emflon PFR can be operated at higher temperatures for shorter time periods.
Forward Flow (Air/Test/Gas) 60:40 IPA: Water wet (v:v)
15 mL/min at 1035 mbar (15 psi)
Aqueous Extractables (20 °C [68 °F])
Water Intrusion 0.33 mL/min at 2485 mbar (36 psi)
< 5 mg per 10 in. (254 mm) element after 1-hour steam at 125 °C (257 °F) (6)
Contact Pall for multi-element values. AB05PFR value is 7.8 mL/min at 2485 mbar
(36 psi).

Ordering Information

AB PFR V

Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(7) Double 226 O-ring with P Pharmaceutical* Oxidation-resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) Omit General Use Other materials available.
hardware
7 Double 226 O-ring with
2 20 in. (508 mm) * Pall pharmaceutical-grade
bayonet lock and fin end
filters are designed for use in
3 30 in. (762 mm) conformance with CGMP in
(7)
AB05 cartridges only.
4 40 in. (1016 mm) Manufacturing, Processing,
Packing or Holding of Drugs
(21CFR210) and CGMP for
This is a guide to the part number structure and possible options only.
finished Pharmaceuticals
For availability of specific options, please contact Pall.
(21CFR211.72) including
batch release certificate and
124 full traceability.